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Bluejay completes SYMON-II enrolment for Symphony IL-6 sepsis test, eyes 510(k) filing in H1 2027

🇺🇸 Bluejay Diagnostics, Inc. (BJDX) · Fri 13 Nov 2026

The US diagnostics firm says pivotal enrolment is finished and a backup cartridge site is secured, but its $7.38M cash runway extends only to the second quarter of 2027.

Bluejay Diagnostics said on 12 November 2026, alongside its third-quarter results, that it has completed enrolment in SYMON-II, the pivotal study of its Symphony IL-6 test for sepsis prognosis.

Preliminary data covering 777 evaluable patients showed 28-day mortality of about 18%. The company has not, in the material available, described further analyses from the study.

Bluejay also reported that it has secured an alternative cartridge manufacturing site. It says this was achieved ahead of a contractual deadline set by Toray, its existing manufacturing partner. The company plans to submit a 510(k) application to the US Food and Drug Administration in the first half of 2027.

On finances, Bluejay reported cash of $7.38M, which it says will last only through the second quarter of 2027. The company therefore states that additional financing will be needed. As general context, a 510(k) is the premarket notification route in which a device maker shows its product is substantially equivalent to a legally marketed device.

What it means for your team

  • Completed enrolment moves SYMON-II towards analysis and the planned H1 2027 510(k) submission, though the final data and FDA review outcome remain outstanding.
  • A second cartridge manufacturing site reduces supply dependence on a single contractor, a point quality teams assess when evaluating diagnostic suppliers.
  • The stated cash runway to Q2 2027 sits close to the planned filing window, so financing could affect the timeline.

Company's press release (SEC filing): Bluejay Diagnostics, Inc. ↗

Article written by VigiEye from the official source (Bluejay Diagnostics, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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